Position Summary:

The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS). The position is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Substances meet regulatory requirements and internal Vera standards.

Responsibilities:

• Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.
• Support implementation of strategies and tactics to promote and maintain GxP compliance.
• Provide quality support on tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of cell banks, commercial and clinical DS.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Provide quality support for validations including process validation, shipping validation, cleaning validation, etc.
• Provides support during both internal and regulatory agency audits as required.
• Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Participate in Quality Agreements negotiation with external partners.
• Support product lifecycle and continued process verification.
• Availability for 5-15% travel, both domestically and internationally.

Qualifications: 

• Bachelor’s degree with 10+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field or a Master’s degree with 7+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field.
• Minimum 6+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, and preferably direct work experience in either Manufacturing or QC, as well.
• Excellent written and verbal communication skills, including demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners and biologics DS manufacturing.
• Experience working with Cell Bank is a plus.
• Experience with process validation is a plus.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.

Role

The AI Team at Vivodyne tackles some of the hardest and most interesting challenges in science and engineering. With access to extraordinarily feature-rich and massive-scale Vivodyne human tissue imagery, we are advancing the frontiers of artificial intelligence and its applications in biology. We are building a portfolio of AI technologies to automate the discovery, development, and de-risking of novel therapies using our unique technology platform, including single-cell 3D phenomics/machine vision, multimodal (multi-omic) translation, and reinforcement learning for robotic planning & study design, among others.

As an AI Senior Scientist, you will leverage your deep expertise in developing large-scale models (including Transformer, Diffusion, and hybrid architectures) and Generative AI solutions to help turn our state-of-the-art imaging and multi-omics datasets into groundbreaking scientific insights. You will collaborate closely with biologists, engineers, and AI specialists to deliver robust, production-ready algorithms and models that power Vivodyne’s high-impact discoveries.

This role will be based on-site at our offices in Brisbane, California

Responsibilities

• Scientific Innovation — Work closely with internal and external stakeholders to understand their scientific objectives and innovate new approaches that utilize Vivodyne’s massive-scale imaging and multi-omics datasets.

• Model Development — Lead hands-on development of cutting-edge machine learning models (Transformers, Diffusion, hybrid architectures, etc.) with a focus on image processing, image enhancement, and Phenomap embeddings.

• Data Pipeline Optimization — Build and deploy pipelines capable of scaling to petabyte-scale data, ensuring robust MLOps practices on AWS or equivalent cloud platforms.

• Multimodal Integration — Explore and develop novel methods to incorporate multi-omics data into imaging-based Phenomaps, advancing the state of the art in multimodal phenotypic analysis.

• Collaboration & Communication — Partner with tissue engineers, microfluidics experts, and robotics engineers to refine data collection strategies, provide feedback on imaging system performance, and identify opportunities for improved AI-driven solutions.

• Scientific Rigor & Leadership — Uphold scientific excellence through peer reviews, proper documentation, and clear communication. Drive a culture of continuous improvement, best practices, and adherence to rigorous research methodologies.

• Scalability & Efficiency — Emphasize modularity, composability, and performance efficiency in designing and implementing high-throughput compute and analytics pipelines.

• Domain & Technical Growth — Remain current with the latest research trends in Generative AI, biomedical imaging, cloud computing, and data-intensive training. Proactively share knowledge and mentor teammates to foster overall organizational expertise.

Requirements and Expectations

• Scientific Excellence — Stay current with AI/ML research, especially in Generative AI, Transformers, Diffusion models, and multi-modal architectures. Apply rigorous, data-driven methods for sound outcomes.
• Hands-On Leadership — Set high standards for model development and code quality, mentoring team members and fostering innovation.
• Accountability — Own model and infrastructure development from concept to deployment, delivering reliable, scalable solutions aligned with Vivodyne’s mission.
• Problem Solving & Adaptability — Develop creative solutions to novel research challenges, thriving in a fast-paced, dynamic startup environment.
• Collaboration & Communication — Work cross-functionally to align AI strategies with business goals, ensuring clear communication and consensus-building.
• Delivering Results — Prioritize impactful research, using project management best practices to track progress, mitigate risks, and meet deadlines.
• Architecture & Coding — Design scalable, cost-effective systems and produce clean, well-documented code with continuous testing and governance compliance.
• Resource Optimization — Apply financial discipline to maximize the efficiency of compute, storage, and third-party services.
• Team & Thought Leadership — Foster an inclusive environment, mentoring future leaders and representing Vivodyne in AI research and industry discussions.

Qualifications

• Education & Experience

• PhD in Computer Science, Applied Mathematics, or a related field, or equivalent practical experience.
• Proven expertise developing and deploying advanced ML architectures (Transformers, Diffusion, multi-modal models) in Generative AI settings.
• Demonstrated history of success with image processing and large-scale model training.

• Technical Skills

• Strong knowledge of AWS or another major cloud provider for MLOps, big data processing, and scalable computing.
• Experience building models for petabyte-scale datasets and understanding the associated architectural and operational complexities.

• Domain Expertise (Preferred)

• Familiarity with biological or biomedical imaging; advanced knowledge in multi-modal Phenomaps, especially integrating imagery with multi-omics data, is a major plus.

• Additional Desired Skills

• Prior experience with HPC, GPU clusters, or distributed computing frameworks.
• Comfortable with container orchestration and open-source data engineering/ML frameworks.

• Soft Skills & Leadership

• Strong written and oral communication skills, with a proven ability to present complex technical topics to non-experts.
• Demonstrated ability to thrive in ambiguous environments, driving clarity and direction with minimal supervision.

Vivodyne, Inc. is an equal opportunity employer. Vivodyne complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.